MAUDE Adverse Event Report: ST PAUL PORT-A-CATH IMPLANTABLE ACCESS SYSTEM; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Model Number 21-4453-24

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Event Description

It was reported that during removal, the catheter broke off from the chamber and moved towards the heart.That same day, the patient was transferred to a clinic for a minimally invasive catheter intervention (miki) to remove the foreign body.

Manufacturer Narrative

Device evaluation: one device was returned for investigation.Two pictures attached to the complaint where it was observed the port with a section attached to the port and a remained catheter section.Visual inspection observed that a section of catheter was attached in the port-catheter connection section under the sleeve, thus, the complaint was confirmed.A destructive test was performed on one (1) sample that was taken from the manufacturing process.Then a catheter piece for the corresponding model was inserted and manipulated in order to pull the catheter to attempting reproduce the failure mode.It was necessary keep the sleeve on the bottom of the tube to remove the catheter without damage; when the catheter was just pulled allowing that the sleeve ascend, a catheter piece was trapped in the sleeve.Instructions for use address this warning.Root cause cannot be associated with manufacturing process since the failure could not be reproduced following the assembly process.The most probable root cause is that damage occurred after the product left the manufacturing facilities.Root cause could not be established.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No corrective actions are required since the root cause could not be attributed to the manufacturing process.

• Brand Name: PORT-A-CATH IMPLANTABLE ACCESS SYSTEM
• Type of Device: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16898662
• MDR Text Key: 314863757
• Report Number: 3012307300-2023-05420
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586032684
• UDI-Public: 10610586032684
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21-4453-24
• Device Catalogue Number: 21-4453-24
• Device Lot Number: 4276230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White